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A North Carolina federal district court will hear the first 16 lawsuits against Merck alleging the pharmaceutical giant’s Gardasil human papillomavirus (HPV) vaccine caused injuries.
The lawsuits were selected as exemplar cases from a larger pool of lawsuits pending in the U.S. District Court for the Western District of North Carolina. They will serve as a series of “bellwether trials,” the outcome of which will shape the process for the growing number of claims brought against Merck for Gardasil-related injuries.
There are currently about 80 cases pending in federal court, with hundreds more cases likely to be filed in federal court in the coming months.
In August 2022, a judicial panel ordered the consolidation of more than 31 lawsuits then pending against Merck into multidistrict litigation in a single court. The panel said the individual lawsuits involve common questions of fact and consolidation would “promote the just and efficient conduct of the litigation.”
The consolidation order allows Gardasil lawsuits filed throughout the country to move into coordinated discovery and pretrial proceedings.
Merck opposed the consolidation, alleging that publicity surrounding the consolidation would “spread misinformation about vaccines,” ”increase vaccine hesitancy” and could cause a flood of “meritless” vaccine injury claims. However, the court disagreed.
Gardasil is a widely used vaccine commonly administered to teens and young adults before they are sexually active to protect against nine of more than 200 strands of HPV, which can be sexually transmitted later in life.
HPV infections may lead to the development of cervical cancer. However, most infections are benign and resolve on their own.
Merck’s clinical trials for Gardasil did not test whether the vaccine protected against cancer.
Merck markets the vaccine as “safe and effective,” but the lawsuits allege the drugmaker fast-tracked Gardasil through the U.S. Food and Drug Administration’s (FDA) approval process and deceptively conducted clinical trials to mask serious side effects and exaggerate the vaccine’s effectiveness.
Some of the signature impacts observed following HPV vaccination — which afflict a number of the plaintiffs — include permanently disabling autoimmune and neurological conditions such as postural orthostatic tachycardia syndrome (POTS), fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome.
There have been thousands of reports of adverse events worldwide, peer-reviewed scientific literature from the U.S., Australia, Denmark, Sweden, France and Japan, and statistics published by public health agencies in each of these countries that demonstrate associations between HPV vaccination and autoimmune conditions.
In the motion for consolidation, plaintiffs’ attorneys from the Wisner Baum law firm wrote that all of the cases address questions of whether Gardasil can cause autoimmune disorders, whether Merck adequately warned of Gardasil’s risks and whether Gardasil caused plaintiffs’ injuries.
From the multidistrict litigation pool, the plaintiffs selected five of the bellwether cases, Merck selected five, four were selected at random, and U.S. District Judge Robert J. Conrad Jr., who will preside over the cases, selected two of the cases.
Discovery is in process and the cases will be tried in late 2024 or early 2025.
Yes, vaccine-injured people can sue Big Pharma in some cases
Vaccine makers are protected from liability for injuries caused by a fully licensed vaccine if that vaccine is listed on the Centers for Disease Control and Prevention’s childhood vaccination schedule.
But it doesn’t mean they can never be sued for vaccine injuries from protected vaccines.
People injured by vaccines listed on the childhood schedule must first seek compensation through the National Vaccine Injury Compensation Program (VICP), also known as the “vaccine court.”
The VICP is a special no-fault tribunal alternative to the traditional legal system set up to resolve vaccine injury claims for 16 federally recommended vaccines. Since it began in 1988, the VICP — despite its shortcomings — has awarded $4.9 billion to more than 8,000 families for vaccine injuries.
Payouts, including attorneys’ fees, are funded by a 75-cent tax per vaccine. There is a $250,000 cap on pain and suffering and death benefits.
But many people are unaware that claimants who are dissatisfied with the outcome of the VICP process can sue the pharmaceutical company directly in civil court, as long as that claimant completed the VICP process, plaintiffs’ attorney Michael Baum told The Defender.
Once an injured person files a case with the VICP, the VICP has 240 days to respond to complete the process. Injured people who choose not to accept the vaccine court’s judgment can opt out of the program, and elect to file a Gardasil lawsuit in civil court.
Baum told The Defender the vaccine court has paid out more than $70 million to people making claims regarding Gardasil, but that over the last few years, without explanation, the court stopped making payments for autoimmune conditions.
The lawsuits against Merck — including the bellwether cases — alleging the HPV vaccine caused debilitating autoimmune complications were brought by claimants who went through the VICP process, but were dissatisfied with the outcome and decided to sue Merck.
But a claimant has only three years from the onset of vaccine-related symptoms to file a complaint with the VICP.
“We think there is some unfairness in the way that statute of limitations is applied,” Baum told The Defender, because autoimmune disorders are challenging to diagnose, and many people are not diagnosed until the statute of limitations for their injury has expired.
Some people don’t realize their autoimmune conditions are linked to Gardasil, Baum added, “because they’ve been told that Gardasil is safe and effective.”
Because doctors and families are told adverse reactions to Gardasil are rare, they often don’t make the connection until the statute of limitations has expired.
It is important for people who believe they have been injured by Gardasil to contact a lawyer and submit a claim as soon as possible. Baum advised anyone who thinks they or their child was harmed by the Gardasil HPV vaccine may have a legal claim, and Wisner Baum can provide a free evaluation.
As the plaintiffs’ lawyers prepare the bellwether cases for trial, they are continuing to investigate and file new lawsuits for people experiencing side effects from Gardasil.
‘Safe and effective’?
While Merck markets Gardasil as “safe and effective,” safety signals emerged early, during the vaccine’s clinical trials. However, the FDA granted the vaccine Fast Track approval after only a six-month review process.
The drug was tested for prevention against the development of certain lesions associated with HPV — the majority of which resolve on their own — not for the prevention of various cancers associated with HPV.
Merck’s own studies show that for those previously exposed to HPV (a huge percentage of the population), when vaccinated, there is an up to 44.6% increased risk of developing advanced abnormal pre-cancer cells or worse.
In 2006, Gardasil was licensed across the U.S. and Europe. But within a few years, reports of serious adverse events appeared — first in the media and then in academic journals — with top scientists calling for more transparent reporting on Merck’s clinical trial data and a re-analysis of its results.
Since then, more adverse events have been reported for Gardasil than almost any other vaccine, with the exception of the COVID-19 vaccine.
Merck maintains a private database, the Merck Adverse Event Reporting and Review System (MARRS) — Merck’s version of the Vaccine Adverse Event Reporting System (VAERS) — that likely contains all of the reports pertaining to Gardasil adverse events submitted by physicians, patients and publications.
After the company refused to make the entire database publicly available, Judge Conrad in April ordered Merck to turn over MARRS to plaintiffs.
In addition to the wide range of autoimmune issues reported to be associated with Gardasil, evidence also suggests the vaccine can cause premature ovarian failure, which often results in an inability to bear children.
Studies summarized in a position statement by Wisner Baum also show that young women who received the Gardasil vaccine have a false sense of security and often forgo routine Pap tests, long recommended as the most effective way to combat cervical cancer, which is largely treatable if caught early.
Data show that countries with high Gardasil uptake also have increased cancer rates in younger women, whereas older women who have followed the Pap test schedule but have not been vaccinated have decreased rates.
And Merck-funded researchers continue to test ways to increase vaccination uptake among children.